Senior Quality Systems Manager

vor 18 Stunden


Visp, Schweiz Actalent Vollzeit

We are seeking a Senior Quality Systems Manager to ensure compliance with ISO/cGMP quality system requirements. The ideal candidate has in-depth knowledge of PICS Guide to Good Manufacturing Practices (Parts 1 and 2) or the EU Guidelines to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, including Annex 1.

Responsibilities:

  • Verify compliance with ISO/cGMP quality system requirements.
  • Provide immediate support to operations and quality control staff for compliance-related concerns (QA "on-the-floor" support).
  • Make independent quality-related decisions based on regulatory and compliance knowledge.
  • Provide independent quality support to project teams.
  • Audit internal quality system elements in manufacturing and operational support areas.
  • Oversee compliance of Change Controls, CA/PA, investigations, OOS, and deviations.
  • Perform external audits of suppliers/vendors/off-site facilities.
  • Lead and direct the work of others as needed.
  • Review and approve validation documents.
  • Review Master Batch Records (MBR) and supporting documents.

Must-Haves:

  • Direct QA commercial drug substance/drug product experience or equivalent aseptic processing and cell therapy manufacturing experience.
  • GMP compliance and Part 11 compliance knowledge preferred.
  • Experience with oversight of aseptic processing and associated international regulations.
  • Proficiency in Microsoft Office and database management.
  • 5-10 years of relevant experience.

Location: Visp

Duration: 6 months

If you feel confident about this opportunity, we encourage you to apply or reach out via email.

Seniority level: Mid-Senior level

Employment type: Full-time

Job function: Quality Assurance

Industries: Pharmaceutical Manufacturing

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